Osteoporosis Screening Trial

NCT01677637 | Completed

• 1 other identifier: 2011-BOD-EL-02
• Study Type: observational
• Target: 5,500
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoporosis is the most common disease of bone and characterized firstly by low bone mass and secondly, impaired bone microarchitecture structure resulting in reduced strength and increased risk of fracture. Osteoporosis is divided into: primary (Postmenopausal Osteoporosis Osteoporosis \& elderly and senile osteoporosis) and secondary. The most common form is postmenopausal osteoporosis. It occurs in women after menopause and is associated with decreased estrogen production, which normally occurs at this age women Osteoporosis usually occurs after age 50, it is very common in women than in men, and its frequency increases with advancing age.

Conditions

Osteoporosis

Keywords

osteopenia, postmenopausal

Outcome Measures

Primary Outcomes (1)

• Osteoporosis Indicator

  T-score per female as measured by Holofic Sahara Instrument

  1 year

Study Arms (1)

All measurements

Total measured population

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal females screened for osteoporosis

You may qualify if:

• Females
• Postmenopausal women
• Outpatients screened for osteoporosis
• Women \> 45 years
• Women \< 45 years under menopause
• Women obtained their consent to be measured

You may not qualify if:

• Premenopausal females
• Women without any symptom of menopause
• Women not obtained their consent to be measured

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Iaso Hospital of Athens, Center of Endocrinology and Bone Metabolism

Athens, Kifisias Avenue, 37-39, Maroussi, 15123, Greece

Location

Related Publications (4)

• Kanis JA. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: synopsis of a WHO report. WHO Study Group. Osteoporos Int. 1994 Nov;4(6):368-81. doi: 10.1007/BF01622200.

  PMID: 7696835 BACKGROUND

• McClung M. Difference in Distribution of T-scores Among Bone Density Tests in Postmenopausal Women. Bone Vol. 23, (5S), pg. S193, 1998.

  BACKGROUND

• Ikeda Y, Iki M, Morita A, Aihara H, Kagamimori S, Kagawa Y, Matsuzaki T, Yoneshima H, Marumo F; JPOS Study Group. Age-specific values and cutoff levels for the diagnosis of osteoporosis in quantitative ultrasound measurements at the calcaneus with SAHARA in healthy Japanese women: Japanese population-based osteoporosis (JPOS) study. Calcif Tissue Int. 2002 Jul;71(1):1-9. doi: 10.1007/s00223-001-2079-6. Epub 2002 Jun 20.

  PMID: 12200654 BACKGROUND

• Magkos F, Manios Y, Babaroutsi E, Sidossis LS. Quantitative ultrasound calcaneus measurements: normative data for the Greek population. Osteoporos Int. 2005 Mar;16(3):280-8. doi: 10.1007/s00198-004-1670-x. Epub 2004 Jul 6.

  PMID: 15241583 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Aristeidis Kerasiotis, Endocrinologist

  Director of Endocrinology Unit ,'Iaso' Hospital of Athens, 37-39 Kifisias avenue, 15123, Athens, Greece

  STUDY CHAIR

• Ioannis Lentzas, MD

  Director, Medical State Center, Simopoulo, Perfecture of Ilia

  PRINCIPAL INVESTIGATOR

• Dimitrios Tsorntanidis, MD

  Registrat B', Medical State Center, Erymantheia, Achaia Perfecture

  PRINCIPAL INVESTIGATOR

• Maria Chronopoulou, MD

  Registrat B', Medical State Site, Diakofto, Achaia Perfecture

  PRINCIPAL INVESTIGATOR

• Olimpia Raftopoulou, MD

  Registrat B', Medical State Site, Myrsini, Perfecture of Ilia

  PRINCIPAL INVESTIGATOR

• Stylianos Danelakis, GP

  Medical State Site, Leontari

  PRINCIPAL INVESTIGATOR

• Thomas Simos, GP

  Medical State Site, Anavra

  PRINCIPAL INVESTIGATOR

• Theofanis Tsirogiannis, GP

  Medical State Site, Agnantero

  PRINCIPAL INVESTIGATOR

• Konstantinos Vatalis, GP

  Medical State Site, Tsartsani

  PRINCIPAL INVESTIGATOR

• Ioannis Antonopoulos, GP

  Medical State Site, Ampelonas

  PRINCIPAL INVESTIGATOR

• Labros Kontovos, GP

  Medical State Site, Nikaia, Perfecture of Larisa

  PRINCIPAL INVESTIGATOR

• Chara Kalliora, GP

  Medical State Site, Gomfon, Perfecture of Trikala

  PRINCIPAL INVESTIGATOR

• Athanasios Misios, GP

  Medical State Site, Megala Kalyvia

  PRINCIPAL INVESTIGATOR

• Antonis Monastiriotis, GP

  Medical State Site, Oropos - Chalkoutsi

  PRINCIPAL INVESTIGATOR

• Zeppos Monstratos, GP

  Medical State Site, Marathonas

  PRINCIPAL INVESTIGATOR

• George Sakellaropoulos, Orthop.

  Medical State Site, Marathonas

  PRINCIPAL INVESTIGATOR

• Andreas Sotiriou, Orthop.

  Private Office, Zografou, Athens

  PRINCIPAL INVESTIGATOR

• Maria Degaiti, GP

  Medical State Site, Ano Mera, Island of Mykonos

  PRINCIPAL INVESTIGATOR

• Aristeidis Frydas, Medical Internist

  Director, Medical State Center, Plomari, Island of Lesvos

  PRINCIPAL INVESTIGATOR

• Nikolaos Tsamouras, GP

  Medical State Center, Agiassos, Island of Lesvos

  PRINCIPAL INVESTIGATOR

• Ioannis Komninos, GP

  Medical State Center of Neapolis

  PRINCIPAL INVESTIGATOR

• Nikolaos Tsakountakis, GP

  Medical State Center of Kastelli, Creta Island

  PRINCIPAL INVESTIGATOR

• Emmanouel Paterakis, GP

  Private Madical Office, Heraklion, Creta Island

  PRINCIPAL INVESTIGATOR

• Panagiota Gourgoulia, MD

  Regional State Medical Center of Giannouli - Tyrnavos, Perfecture of Larisa, Greece

  PRINCIPAL INVESTIGATOR

• Zisis Kelepouris, GP

  Regional State Medical Center Platanos-Raxa, Perfecture of Trikala, Greece

  PRINCIPAL INVESTIGATOR

• Christos Ganochoritis, GP

  Medical State Center of Pyrgetos and Egani, Regional Perfecture of Larisa

  PRINCIPAL INVESTIGATOR

• Demetra Zambouka, GP

  Medical State Center of Agioi Anargyri, Regional Perfecture of Larisa

  PRINCIPAL INVESTIGATOR

• Charalampos Terzopoulos, MD, Orthopedics

  Private office, Zografou, Athens, Greece

  PRINCIPAL INVESTIGATOR

• John Sakellariou, MD, Pathology, Registrat A

  Medical Center of Farkadona, Thessalia, Greece

  PRINCIPAL INVESTIGATOR

• Aglaia Roganaki, MD, Registrat B,

  Peripheral Medical Center of Mitropolis, Thessalia, Greece

  PRINCIPAL INVESTIGATOR

• Vasilis Delezos, MD, Registrat B

  Medical Center of Sophades, Thessalia, Greece

  PRINCIPAL INVESTIGATOR

• Victoria Katsouri, MD, Registrat B

  Medical Center of Sophades, Thessalia, Greece

  PRINCIPAL INVESTIGATOR

• Maria Papala, MD

  State Medical Center of Tyrnavos, Thessalia, Greece

  PRINCIPAL INVESTIGATOR

• Styliani Papakosta, MD, Phyciatry

  Medical Private Office, Larisa, Greece

  PRINCIPAL INVESTIGATOR

• Athanasios Tsivgoulis, MD in Physiatry

  Medical Diagnosis Center, Lesvos Island, Greece

  PRINCIPAL INVESTIGATOR

• Petros Prokopis, MD

  Medical Office of Avlona

  PRINCIPAL INVESTIGATOR

• George Papadimitriou, MD, Orthopedics

  Private Medical Office, Vari Attikis

  PRINCIPAL INVESTIGATOR

• Vasilios Hamos, MD, Director

  State Medical Cener, Agia, Larissa

  PRINCIPAL INVESTIGATOR

• Lemonia Arvanitakou, MD

  State Medical Center, Agia, Larissa

  PRINCIPAL INVESTIGATOR

• Victoria Rizou, MD

  State Medical Office, Halki, Larissa

  PRINCIPAL INVESTIGATOR

• Vassiliki Mamakou, MD, Internist

  Mytilini

  PRINCIPAL INVESTIGATOR

• Antonios Partsinevelos, MD, Orth

  Private Office, Marousi, Athens

  PRINCIPAL INVESTIGATOR

• George Patoulis, MD, Orth

  Private Office, Marousi, Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start: February 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 19, 2014

Record last verified: 2013-05

Locations

GR (1)